GMP dei dispositivi medici cinesi vs. ISO 13485:2016: La guida definitiva clausola per clausola

ISO 13485:2016 vs. China Medical Device GMP Comparison | Technical Reference

Comparison between ISO 13485:2016 and China New Medical Device GMP

A detailed technical mapping based on the latest NMPA Inspection Principles for international manufacturers.

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		and determine the design and development of each departmentActivities andinterface,clearResponsibilities and division of labor.
		When reviewing design and development planning documents, the design and development activities should be planned according to the characteristics of the product, and the planning results should be documented. This should include at least the following:content:
		1.Design and development projectsTargetandDescription of meaning
		Narrative,Technical indicator analysis;
		2.ConfirmedDesign and development phasesAnd suitable for each design and development stage.Review, verification, validation and design transferActivity;
		3.The design and development of each department should be identified and determined.Activities and Interfaces,clearResponsibilities of personnel or organizations at each stage,Composition of the review panel,as well asExpected output results at each stage;

		4.Planning and arranging main tasks and phased tasks in relation to the entire projectConsistent;

		5.SureProduct Technical RequirementsofFormulate, verify, confirmandMeasuring devices required for production activities;

		6.Risk ManagementActivity.
		The design and development should be implemented in accordance with the plan.Deviation from PlanWhen it is necessary to modify the plan, it should be done as follows:The plan will be reviewed and approved again..
	7.3.3 Design and development input	5.3.1	1)13485Emphasis on usabilityRequest, and require that it meets the following conditions.IEC 62366-1Requirements; and inspectionThe principle was not explicitly emphasized.
	The requirements related to the product should be determined.enterand maintainRecord(See4.2.5)These inputs should include:	Design and development inputs should includeIntended Use SpecificationSpecific functional, performance, and safety requirements, and regulatory requirements.,Risk management and control measuresandOther requirements.	2)13485When appropriate, designThe development inputs include information provided by previous similar designs, while the inspection principles are not proposed.
	a)in accordance withIntended Use,Functions, performance,AvailabilityandSafetyRequire;	5.3.2
	b)ApplicableRegulatory requirementsandstandard;	Design and development inputs should be analyzed.Reviewand obtainedarriveapprove,KeepRelated records.
	c)ApplicableRisk management output;
	d)When appropriate, previouslySimilar designInformation provided;
	e)The design and development of products and processes are necessaryOther requirements;
	Requirements shouldComplete and clear, can beVerify or confirm,
	And it cannot be self-contradictory.
	Note: Further information can be found at [link/reference].IEC 62366-1.
	7.3.4 Design and development outputDesign and development outputs should:	*5.4.1	Inspection principles are relatively13485 More detailedbody
	a)satisfyDesign and development inputRequirements;	Design and development outputs shouldMeets input requirements,includeProcurement, production and serviceRequired relevant informationProduct Technical Requirementswait.
	b)GiveProcurement and productionandService providedAppropriate
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	information;	Review the design and development output materials; they should at least meet the following requirements.The following requirements are made:
	c)Include or referenceProduct Acceptance Criteria;	1.Procurement Information,likeRaw materials, packaging materials, assembly
	d)Regulations on productsSafe and normal useRequiredProduct Features;	Technical requirements for parts and components;
	Design and development outputformShould be suitable for designand development inputverifyAnd should be before publicationbatchallow.	2.Production and service needsInformation, such asProduct drawings
	The design and development outputs should be maintained.Record(See	(including component drawings))Process formulation, work instructions, environmental requirementswait;
	4.2.5).	3.Product Technical Requirements;
		4.productInspection procedures or instructions;
		5.Specified productsProduct characteristics necessary for safety and normal usesuch as productsInstruction Manual,Packaging and labeling requirementsEtc. Does the product instruction manual match the notes?
		The registration application and approval are consistent;
		6.Identification and traceabilityRequire;
		7.Submit toRegistration and approval departmentFiles, such asResearch data, product technical requirements, registration test reports, clinical evaluation data (if any))List of basic requirements for the safety and effectiveness of medical deviceswait;
		8.prototype or sample;
		9.Biological evaluation results and records,includeMain performance requirements of materials.
		5.4.2
		The design and development outputs should be receivedapproveMaintain phasecloseRecord.
	7.3.5 Design and development review	5.6.1	13485 Emphasis was placed on design and development reviewsThe participants.
	existAppropriate stageThe design and development should be systematically carried out in accordance with the planned and documented arrangements.Review,so that:	It should be arranged at an appropriate stage of design and development.CommentsTrial,KeepReview resultsand anyNecessary measuresThe recordrecord.
	a)Evaluation of design and developmentThe results meet the requirements.ofability;	Review relevant documents and records, ensuring at least the following requirements are met.beg:
	b)Identify and proposeNecessary measures.	1.It should be based on the results of the design, development, and planning.suitable
	ReviewParticipantsThis should include the design and development phases being reviewed.Representatives of relevant functionsOtherofexpert.	stageConduct design and development reviews;
	ReviewResults and any necessary measuresofRecordShould be	2.Design and development reviews should be maintained.Record,includeReviewresultand the review adoptedNecessary measuresThe recordrecord.
	Keep(See4.2.5).
	7.3.6 Design and development verification	5.6.1	1)13485Emphasis was placed on the method and reception.Criteria, and the statistical techniques and principles used to determine the sample size;
	To ensure that the design and development outputs meet the design and development requirements	Design and development should be carried outverifyTo ensure that the design and development outputs meet the input requirements and maintainVerification resultsand anyNecessary measuresShi’s records.	2)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined;
	Input requirements should be based on the planned and documented arrangements for design and development.verify.	Review relevant documents and records, ensuring at least the following requirements are met.beg:	3)The inspection principle emphasizes the availability of options.
	The organization should include a validation plan.Create document,includesquare	1.The results of the planning should be considered in conjunction with the actual situation.Appropriate stage
	Law, Acceptance CriteriaWhen appropriate, to determineSampling sizeThe adoptedStatistical Techniques and Principles.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementThe verification should include the following:Connection or engagementAt that time, it was confirmedThe design output satisfies the design input.The content.	Conduct design and development verification to ensure that the design and development outputs meet the input requirements;	The calculation method or the method of comparison with the proven design should be used.Appropriateness of the methods used in the reviewSexuality, whether the confirmation method is scientific andefficient.
	Verification resultsandin conclusionas well asNecessary measuresofRecord	2.Design and development verification should be maintained.Record,verify
	It should be maintained.(See4.2.4 and4.2.5).	resultand anyNecessary measuresRecords;
		3.If the design and development verification usesAvailableCalculation methodorComparison of proven designsMethodThe methods used should be reviewed.suitablesexTo confirm whether the method is scientific and effective.
	7.3.7 Design and development confirmation	5.8.1	1)13485Emphasis on methods and receiving accuracyTherefore, when appropriate, the statistical techniques used to determine the sample size should be consistent with the original principles.reason;
	To ensure the product canMeets the applicable requirementsor requirements for intended useIt should be based on the planned and writtenComponent-based arrangements for design and developmentconfirm.The organization should confirm the plan.Create document,includesquareLaw, Acceptance CriteriaWhen appropriate, forDetermine the sample sizeStatistical techniques and principles employed.	Design and development should be carried outconfirmTo ensure productionProduct satisfactionSpecified usage requirements or intended useRequirementsAnd keep confirmingresultand anyNecessary measuresofRecord.	2)13485Clearly require representative samplesProduct design confirmation;
	responseRepresentative productsDesign confirmation was conducted, with representative products includingThe initial production unit, batch, or other equivalentThe information used for confirmation should be recorded.Product Combinationreason(See4.2.5).	Review relevant documents and records, ensuring at least the following requirements are met.beg:	3)13485Explicitly require recording forVerify the product’s suitability;
	As part of design and development verification, the organization shouldaccording toApplicable laws and regulationsRequired to conductClinical evaluation orPerformance Evaluation.	1.Should be inSuitable stageDesign and development	4)13485Clearly for clinical evaluationMedical devices that have undergone performance evaluation should not be considered as released for customer use.
	ForClinical evaluation or performance evaluationofmedical devices	Recognize and ensure product quality.Requirements for meeting the specified usage or intended use;	5)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined.
	This should not be considered as permission for customers to use..	2.Design and development validation activities should be conducted during product development.Before delivery and implementationconduct;
	If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementConfirmation should include this linkWhen connecting or joining, confirm the applicable requirements or pre-defined conditions.	3.Design and development verification records should be maintained, includingClinical evaluation or clinical trialRecord the results and any necessary actions taken.
	The intended use has been fulfilled.	5.9.1
	Confirmation should be made on the productBefore delivery to the customeroverbecome.	Confirm that clinical or performance evaluation methods are suitable.When conducting clinical trials,Compliant with medical device clinical trialsTesting regulationsRequirements.
	confirmresultandNecessary measuresofRecordShould be maintained	CheckClinical evaluation reportand its supporting materials. If open
	(See4.2.4 and4.2.5).	For clinical trials to be conducted, the clinical trials must comply with the law.The regulations require and corresponding supporting documentation must be provided. For those requiring…
		Medical devices requiring clinical or performance evaluationThe equipment should be able to provide an evaluation.Reports and/or materialsmaterial.
	7.3.8 Design and development conversion	5.5.1	1)The inspection principles have further refined the specific content of design and development transformation activities.Allow;
	Organizations should transfer design and development outputs to manufacturing.changeChangeThe procedures are documented. These procedures should ensure the design…	Design should be carried out during the design and development process.From development to productionConversionActivities to enable design and developmentThe output was developed before becoming the final product specification.Verification ensures that the design and development outputs are validated.Suitable for life	2)The inspection principles emphasize product technology.beg.
	The output of development becomes the final production specification.PreviouslySuitable for productionthroughverify,andProduction capacity can meet product requirements.	Produce.
	Transformedresultandin conclusionIt should be recorded.(See	The relevant documents must meet at least the following requirements:
	4.2.5).	1.Design should be carried out during the design and development process.conversionActivityTo solveManufacturability, Componentsand the availability of materials, the required production facilities
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Training of equipment and operatorswait;
		2.Design transformation activities should incorporate the product’s…Each technical requirementCorrectly translate into product realizationRelatedSpecific process or procedure;
		3.Records of design conversion activities should indicate that the design conversion activities were completed.Design and development output in becomingFinal product specificationsFan Qian’s statement has been verified.and retainVerification records,To ensure the design and developmentOutput suitable for lifeProduce;
		4.Special processes should be addressed.Confirm conversionIndeed
		Ensure the results are applicable to production and retain confirmation records.record.
	7.3.9 Control of design and development changes	5.10.1	The inspection principles have been further refined in design and development.The revised review record requirements.
	The organization should control design and development changes.programCreate documentThe organization should determine the relationship with medical devices.Functionality, performance, usability, securityandApplicable medicalMedical device regulations requireand itsIntended use relatedofHeavyTo change.	The design and development should beChangePerform identification andKeep a record.
	Design and developmentchangeIt should be identified before implementation.,thisThese changes should be:	5.10.2
	a)go throughReview;	Design and development changes should be made when necessary.CommentsReview, verification and confirmationand obtained before implementationapproveView design and development.ChangeofReview Record,At least
	b)go throughverify;	The following requirements must be met:
	c)When appropriate,confirm;	1.It should include changes to theProduct components andImpact of delivered products;
	d)go throughapprove.	2.The implementation of design and development changes should comply withmedicalMedical device product registrationThe relevant regulations;
	The review of design and development changes should includeDuring the processOr already deliveredofComponents and productsChanges andwindRisk ManagementandProduct realization processof	3.The content and results of the design changes involve modifying…ChangeMedical Device Product Registration Certificate (Filing CertificateThe certificate statesWhen discussing content, enterprises should conduct…Risk AnalysisAnd in accordance with the relevant regulations, apply for a change of registration (filing) to meet the requirements.
	Evaluation of the impact of changes in input and output, and modification.ofReview resultsand anyNecessary measuresofRecordShould be maintained(See4.2.5).	It meets the requirements of the regulations.
	Design and development changesReviewIt should include evaluations.Modify product components and work-in-process or delivered	*5.10.3
	The impact on the product, and the evaluation changes.Risk ManagementInput/Output andProduct realizationThe impact of the process.	When selectedMaterials, parts, or product functionsChanges may affect medical device products.Safety and effectivenessWhen making changes, the potential consequences should be evaluated.riskTake measures to mitigate risks when necessary.Reduce to acceptableSubject to levelAt the same time, shouldCompliant with relevant regulationsThebeg.
	7.3.10 Design and development documents	none	Although the inspection principles do not explicitly emphasize maintaining the design and development documentation for each type or family of medical devices in this chapter.However, the actual regulatory process in China requires…It should cover all product models.
	The organization should maintainEach type of medical device or medicalMachine familyThe design and development documents, this document should includeInclude or cite to demonstrate compliance with design and development requirements
	The resulting records, as well as design and development changesRecord.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	none	5.11.1	Although13485 The style was not clearly defined in a separate chapter.Risk management requirements, but in the preceding section “7.1”Product Realization Planning” clearly requires:”During the product realization process, the organization should…”One or more processes of risk management”Create a document”.
		Product implementation, including design and development, should be included.Throughout the entire process, the following was formulated.Risk ManagementThe requirements should be documented and relevant records maintained.
		CheckRisk Management DocumentsandRecordAt least meet the following requirementsThe following requirements are made:
		1.Risk management should cover the realization of the products developed by the enterprise.The whole process;
		2.Documentation for risk management of medical devices should be established and relevant records should be maintained.RecordTo determine the certificate of implementationaccording to;
		3.The risks of medical device products should be controlled withinAcceptable level.
7.4 purchase	7.4.1 Procurement process	*6.1.1	The inspection principles are more detailed within the procurement process.Requirements for content and supplier review.
	Organizations shouldDocumentation procedure(See4.2.4),byEnsure the products purchasedProcurement information that meets the requirementsOrganizations should establish evaluation and selection mechanisms.Supplier guidelines,allow	It should be establishedProcurement control procedures.
	Then it should be:	The procurement process should include at least the following:Procurement process, selection, evaluation and re-evaluation of qualified suppliers, requirements for inspection or verification of procured items, procurement recordsRequirements.
	a)Based on the supplierProvide products that meet the organization’s requirementsability;	*6.1.2
	b)Based on the supplierPerformance;	It is necessary to ensure the procurement of goodsCompliantThe requirements, andNot less thanRelevant provisions of laws and regulationsandNational strengthRelevant requirements of regulatory standards.
	c)based onThe impact of product procurement on the quality of medical devicesring;	6.2.1
	d)Related to medical devicesriskConsistent.	shouldBased on the impact of the purchased items on the product,SureFor purchased itemsThe methods and extent of control.Examine the methods and extent of control implemented over procured items.According to regulations, the verification control methods and extent can meet the requirements.Product requirements.
	Organizations should respond to suppliersSurveillanceandRe-evaluationconductpolicyPlanSuppliers whose purchased products meet the requirements.PerformanceIt should be givenSurveillanceThe results of the surveillance should serve as the supplier’s [resource/resource].Inputs to the re-evaluation process.	6.3.1
	Should be statedUnmet procurement requirementsandCorrespondingly there areSuppliers of products corresponding to risksand in complianceApplicable regulatory requirements.	It should be establishedSupplier audit systemSuppliers should be audited and evaluated. On-site audits should be conducted when necessary.nuclear.
	Supplier evaluationResults, selection, monitoraggio, and reassessmentpriceRecords or actions taken as a result of these activitiesanyNecessary measuresRecords should be kept.	Does it meet the requirements?Guidelines for Supplier Auditing of Medical Device ManufacturersRequirements.
	(See4.2.5).	6.3.2
		When retainSupplierEvaluationresultand the evaluation processRecord.
	7.4.2 Procurement Information	6.5.1	No significant differences
	The procurement information should describe or reference the products to be procured, E, where appropriate, include:	When procuring, procurement information should be clearly stated and the procurement details should be clearly described.Purchase requirements, includingCategories of purchased items, acceptance criteria,Specifications, procedures, and drawingsContent such as…
	a)productspecification;	Randomly check the procurement of relevant items from the procurement list.
	b)Product AcceptanceGuidelines, procedures, processes and equipment
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Requirements;	Purchase requirements, and confirm whether they meet the requirements of this clause.
	c)Supplier personnel qualificationsRequirements;	6.5.2
	d)Quality Management SystemRequirements.	Procurement records should be established, includingPurchase contract, raw material list, supplier qualification documents, quality standards, inspection reports and acceptance criteriawait.
	Before communicating with suppliers, the organization should ensure that…Regulations on procurement requirementsIt is sufficient and appropriate.	*6.5.3
	Where appropriate, any actions that affect the ability of purchased products to meet the prescribed procurement requirements.changeBefore implementation, procurement information should be…Includes a written agreementThe supplier shall inform you.	Procurement records should meet the following requirementsTraceableRequire.
	Changes in the organization’s procurement of products.	*6.4.1
	according to7.5.9 RegulationsTraceabilityRequired process	Should be withMajor raw material suppliersSignQuality AssociationDiscussionClearly define the quality responsibilities undertaken by both parties.
	The organization should use documents to determine the degree of organization.(See4.2.4)and records(See4.2.5)To maintain relevant procurement information in a specific format.
	7.4.3 Verification of purchased products	6.6.1	13485 Verification requirements for purchased productsPlease be more specific.
	The organization should establish and implementtestOr other necessaryActivities to ensure procurementThe products meet the specified procurement requirements.Verification activitiesScope and extentShould be based onThe supplier’sEvaluation resultsand the purchase of productsriskConsistent.	The purchased items should be inspected.Inspection or verification,make sureMeet production requirements.
	When an organization becomes aware of any changes in the products it procures…At that time, the organization should determine theseDoes the change affect the product realization process or medical device?.	Check the purchased itemsInspection or verification records.
	When an organization or its customers intend to use the supplierOn-site implementation
	verifyAt that time, the organization should include this in the procurement information.Proposed VerificationArrangementsandProduct release methodRegulations should be established. This should be maintained.verifyRecord(See4.2.5).
7.5product Servicefor	7.5.1 Control of production and service provision	*7.1.1	1)The inspection principles emphasize ensuring that products comply with mandatory standards and are registered.Or the product technology to be registeredbeg;
	To ensure product compliance with regulations, [the following measures should be taken]Provision of production and servicesconductPlanning, implementation, monitoring and controlWhere appropriate, production control should include, but is not limited to, [the following].:	Production should be carried out in accordance with the established quality management system.Production to ensure product complianceMandatory standardsand registered or filedProduct Technical Requirements.	2)The inspection principles emphasize the need to clearly identify key processes and special procedures;
	a)Used for production controlprogram/Method files	*7.2.1	3)The inspection principles have further refined the specific content of production records.
	(See4.2.4);	Production should be preparedProcess specifications and work instructionswait,clearKey processesandSpecial process.
	b)FoundInfrastructure;	Review relevant documents to see if key processes and special procedures are clearly defined, and whether there are provisions for verifying or confirming important parameters of key processes and special procedures.
	c)rightProcess parametersandProduct FeaturesconductSurveillanceandMeasurement;	2.1.1
	d)Acquisition and useSurveillanceandMeasuring device;	Factory buildings and facilitiesIt should conform to the productProduction requirements.
	e)In accordance with regulationsLabelandPackageoperate;	5.2.1
	f)Release,deliverandAfter deliveryImplementation of the activity. The organization should establish and maintain [the necessary procedures].Each (or batch) of medicalinstrumentofRecord(See4.2.5)to provide7.5.9 middleRegulationstraceabilityRecord the scope and extent, and indicateProduction quantityandApproved for saleThe quantity.RecordShould go throughValidation and approval.	5.Determine product technical requirementsFormulate, verify, confirmrecognizeandProduction activitiesRequiredMeasuring device;

		*5.4.1
		5.Regulations necessary for the safety and proper use of the product.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Product Featuressuch as productsInstruction Manual,Packageand
		Labeling requirementsEtc. Does the product instruction manual match the notes?
		The registration application and approval are consistent.
		8.3.2
		Incoming inspection that requires routine controlProcess inspectionand
		In principle, finished product inspection items should not be outsourced.
		Testing. For testing conditions and equipment with high requirements, [the following is necessary]:
		For items requiring testing outsourcing, a qualified testing agency can be commissioned.
		The agency conducts inspections to prove that the product complies with mandatory standards.
		Standards and registered or filed product technologies
		beg.
		*8.5.1
		Products should be specifiedRelease procedure,conditionandRelease batch
		Standard requirements.
		Check the product release procedure to see if the release process is clearly defined.
		Conditions and requirements for release approval. The authority should be specified.
		Personnel authorized to release products and their responsibilities and authority must be protected.
		Hold approved records.
		*9.1.1
		Products should be establishedSaleRecord and satisfyTraceable
		Require
		9.3.1
		It should possess the necessary capabilities appropriate to the products it produces.After-sales service
		Service capabilitiesEstablish and improve the after-sales service system.
		*7.6.1
		Each batch (units) of productsAll should haveProduction Records,E
		satisfyTraceableRequirements.
		7.6.2
		Production RecordsIt should include:Product Name, Specifications
		Number, raw material batch number, production batch number or product number
		Production date, quantity, main equipment, process parameters,
		Operators, etc.content.
		*8.4.1
		Each batch (units) of productsAll should haveBatch inspection record,
		and satisfyTraceableRequire.
	7.5.2 Product cleaning	7.3.1	13485 Further details on which situations require
	The organization should make the productcleanorProduct contamination controlof	During the production process, it is necessary to…Raw materials, intermediate products, ecc.	Product cleaning or product contamination control requirements
	RequireCreate document,if:	conductcleanThose that are handled should be clearly defined.Cleaning methodsand	Please create a document.
	a) existSterilization and/or before useProducts manufactured by the organization	Requireand toCleaning effectconductverify.
	clean;
	b) byNon-sterile formProvided and inSterilization or
	Cleaning should be performed first.Products;
	c)existProducts that cannot be sterilized or cleaned before use
	Taste,Clean during use.yesImportantof;
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	d)byNon-sterile formThe products provided, theirCleaning is essential.of;
	e)From the product during the manufacturing processRemove processing aidsAgent.
	If the product is as described abovea)orb)If cleaning is required, then before cleaning treatment.No need to satisfy6.4.1Require.
	7.5.3 Installation activities	9.4.1	No major differences, inspection principles are slightly more detailedSpecific requirements for installation and maintenance by the user or other enterprise.
	When appropriate, the organization should include medical devicesInstallandInstallation Verification Acceptance CriteriaThe requirements are documented.	Need to beEnterprise installationMedical devices should be determinedInstallRequirements andInstallation verificationofAcceptance Standard,EstablishInstallandAcceptance Record.
	If the customer requests permission, except…organization orOther than its suppliersofExternal installation of medical deviceshour,	9.4.2
	The organization should handle the installation and installation verification of medical devices.Provide documented requirements.	Depend onUser unitorOther companiesFor installation and repair, the following should be provided:Installation requirements, standard, maintenance parts, documentation, passwords, etc.and conductguide.
	It should be maintained that the work is done by the organization or its supplier.Installand
	Verification records(See4.2.5).
	7.5.4 Service Activities	9.3.1	13485 The service records have been further refined.Requirements for tolerance.
	Where service requirements are specified, and when necessary,Organizations should establish [equipment/systems] forService provision activitiesandverifyDocumentation confirming whether the service meets the specified requirements.ofProcedures and Reference MaterialsandMeasurement Procedure.	It should possess the necessary capabilities appropriate to the products it produces.After-sales serviceService capabilitiesEstablish and improveAfter-sales service system.
	The organization should analyzeThe organization or its suppliersImplement service activities	9.3.2
	movingRecord:	shouldAfter-sales service requirementsandEstablish after-sales serviceService Recordsand satisfyTraceableRequirements.
	a)Determine whether the information is used asComplaints are handled;
	b)When appropriate,AsImprovement processofenter. Should be maintainedThe organization or its suppliersThe service activities carried outmovingRecord(See4.2.5).
	7.5.5 Specific requirements for sterile medical devices	《GMP Guidance for On-site Inspection of Sterile Medical Devicesbut”:	1)No significant differences. Detailed specific requirements for sterile medical devices are available.refer to”GMP Sterile medical devicesRelevant regulations, documents, and standards, such as the “Guidelines for On-site Inspection”;
	The organization should maintainEach sterilization batchSterilization process parameter recording(See4.2.5),Sterilization RecordanswerTraceablearriveMedical devicesEach production batch.	7.21.1	2)《GMP Sterile medical devicesThe “Guidelines for On-site Inspection” further refines the sterilization process control documents.content.
		It is necessary to formulateSterilization process control documents,KeepEach sterilization batchThe sterilization process parameters should be recorded, and the sterilization record should be…TraceableTo the productEach production batch.
	7.5.6Validation of the production and service delivery process	7.5.1	13485 The process confirmation has been further refined.Require.
	Organizations should identify the outputs of their production and service provision processes.Cannot or not be followedContinued monitoring or measurement to verifyThe process, because	Production should beSpecial processconductconfirm, and saveRecord,includeConfirm the plan, methods, operators, results evaluation, and reconfirmation.content.
	Therefore, the defect occurs during product use or after service delivery.	7.5.2
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	It will only become apparent later.	Used in the production processComputer software for products Quality is affectedYes, it should be carried outVerify or confirm.
	confirmIt should be able to demonstrate the ability of these processes to consistently achieve the planned results.
	The organization should include the processConfirmation procedure document,Baginclude:
	a)forProcess reviewandApproval stipulationsofallowbut;
	b)equipmentofIdentificationandPersonnel Qualifications;
	c)Use specificmethod,programandAcceptance criteria;
	d)When appropriate, to determineStatistical techniques and principles used in sampling;
	e)RecordRequirements(See4.2.5);
	f)Confirm againIncluding reconfirmationGuidelines;
	g)Process Changeofapprove.
	Organizations should allocate funds for production and service provision.Computer softwareofconfirmThis creates a documented procedure.Software verification should be conducted withinConfirm before first use,appropriateAt this time, hereSoftware changesorAfter applicationWith softItemconfirmandConfirm againofSpecific methodsandActivityanswerRelated to the application of this softwareriskConsistent, includingImpact on product compliance capability.
	The necessity of confirmationmeasureand confirmedresultandin conclusion
	ofRecordIt should be maintained(See4.2.4 and4.2.5).
	7.5.7 Process validation of sterilization and aseptic barrier systemsSpecial requirements	《GMP Guidance for On-site Inspection of Sterile Medical Devicesbut”:	1)13485Specific sterilization methods were mentioned.The process of aseptic barrier systemFor specific requirements, please refer to the relevant documentation.ISO11607-1 andISO 11607-2;
	The organization shouldsterilizationandsterile barrier systemofprocessconfirmThe program forms a file(See4.2.4).	7.20.1	2)Other related to sterile medical devicesFor specific requirements, please refer to the document.GMP noneGuidance on on-site inspection of medical devicesin principle”.
	Where appropriate, the sterilization process and aseptic barrier system should be implemented.Before implementationas well asBefore subsequent product or process changesgo throughconfirm.	Sterilization of sterile medical devices should be established.The process is verified and documented..
	confirmresultandin conclusionAnd the measures taken as confirmed	Check the sterilization process confirmation procedure documents to see if they conform to…Meets the requirements.
	Necessary measuresRecords should be kept.(See4.2.4 and	*7.20.2
	4.2.5).	The sterilization process should be carried out in accordance with relevant standards.Before the first implementationconductconfirmWhen necessaryConfirm again,andMaintain a record of the sterilization process confirmation.
	Note: Further information can be found at [link/reference].ISO 11607-1 andISO 11607-2.	existFirst timeBefore sterilizing the product, is the sterilization process monitored?confirm.existProducts, sterilization equipment, process parameterswaitWhen changes occurShould the sterilization process be carried out?Confirm again.
		Validation of sterilization or aseptic processing proceduresComplies with relevant standards,likeGB18278~GB18280Sterilization Validation and Routine of Medical and Healthcare ProductsRegulation and control requirementsWhether the record or report has been reviewed and approved.
		If aseptic processing technology is used to ensure the sterility of the product, then…
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
		Whether or not in accordance with relevant standards, such asYY/T0567″medicalAseptic processing of therapeutic productsPerformedProcess simulation testTest.
		Has the sterilization process been maintained?Record.
		Sterilization confirmation was used to determine the quality of the initial packaging and the product.Initial contaminant bacteriaandacceptable levels of particulate pollution.
	7.5.8 logo	7.7.1	13485It was emphasized that if applicable regulations apply.The requirements stipulate that organizations should allocate medical equipmentSystematic documentation for the unique identification of mechanical devices;And only in theGMPImplantable medical devicesThe “Guidelines for On-site Inspection” mentions uniqueness.Logo.
	The organization shouldProduct IdentificationofProgram documentation,andUsed throughout the entire product realization processAppropriate methodsIdentify the product.	Products should be establishedIdentification control program,useAppropriate methodsProducts should be labeled for identification purposes to prevent misuse and confusion.
	In product implementationThe whole processIn China, the organization should, according toMonitoring and measurementRequirementsIdentify product statusThroughout the productProduction, storage, and installationandServeDuring the process,KeepProductsStatus indicatorTo ensure that only those who passNecessary inspections and tests or authorized concessions OKOnly products can beSend, use or installIf there isApplicable regulatory requirementsThe regulations stipulate that organizations should respond.System for assigning unique identifiers to medical devicesForming text	*7.8.1
	Item.	Products should be labeled during the production process.Inspection status,preventSubstandard intermediate products flow to downstream processessequence.
	Organizations should establish documented procedures to ensureReturn to organizationAll medical devices can beIdentificationAnd can be withDistinguishing qualified products.	Check whether there are regulations on the method of marking the inspection status, and inspect the inspection status markings in the production process on-site to see if they comply with the regulations.
		*7.9.1
		The product should be establishedTraceabilityProcedures, regulations for productionProduct traceability scope and extentlogoAnd necessary records.
		《GMP On-site inspection guidance for implantable medical devicesin principle”:
		*7.22.1
		A traceability procedure should be established and documented, specifying the scope and extent of traceability for implantable medical devices.Unique identifierAnd the required records.
		Check the traceability procedure documents to see if they specify the scope, extent, unique identification, and required records for traceability of implantable medical devices.
	7.5.9Traceability	*7.9.1	none
	7.5.9.1General Principles	The product should be establishedTraceability proceduresRegulations on productionTasteScope, extent, identification, and necessary records of traceability.
	The organization shouldTraceability proceduresThese procedures should be documented and specified to conform toApplicable regulatory requirementsofCan Scope of traceability, proceduresand placeRecords maintained,
	(See4.2.5).
	7.5.9.2Specific requirements for implantable medical devices	《GMP On-site inspection guidance for implantable medical devicesin principle”:	none
	The records required for traceability should include, but are not limited to, those that may be necessary.guideMedical devices that fail to meet their safety and reliability requirementsCan be requiredofComponents, materials and working environmentenvironmental conditionsThe record.	7.22.1
	The organization should requireResale serviceSuppliers or distributors maintainMedical device distribution recordsso thatTracingWhen inspect	When specifying traceability requirements for records, it should includeIncluding the possibility of finalThe product does not meet its specifications.The required raw materials, production equipment, and operatorsPersonnel and production environmentRecords, ecc.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	This record can be obtained when needed.	Check the product’s labeling, production records, and inspection records to see if the raw materials, production equipment, operators, and production environment used in the product’s production can be traced.content.
	Freight Packaging RecipientofnameandaddressRecordsIt should be maintained(See4.2.5).	9.6.1
		It should be required thatAgents or distributorssaveMedical device distribution recordsso thatTracing.
		9.6.2
		Should be preservedFreight Packaging RecipientofnameandaddressThe record.
	7.5.10 Customer property	none	The inspection principles do not emphasize customers in a separate chapter.Property requirements.
	whenCustomer propertyUnder the organization’s control or use, the organization shall identify, verify, protect, and maintain the resources available to it.Used or constitutes part of the productCustomer property.
	ifCustomer materialsoccurLost, damaged, or found to be unsuitableAt that time, shouldReport to CustomersAnd keep records.
	(See4.2.5).
	7.5.11 Product Protection	7.11.1	The inspection principles have been further refined to include protective equipment.Physical requirements.
	existProcessing, storage, treatment and saleIn this process, organizations document protective procedures to ensure that products meet requirements.ProtectionApplicable to medical devicesComponentsDuring processing, storage, handling, and distribution, when the product is exposed to…Expected situation and harmAt that time, the organization should pass through	Products should be establishedProtectionThe procedure specifies the protection requirements for products and their components, includingPollution protection, electrostatic protection, dust protection, corrosion protection, transportation protection, etc.Requirements. Protection should include…Labeling, transportation,Packaging, storage and protectionwait.
	Protect your product in the following waysAvoid alteration, contamination, O	On-site inspection to verify whether the product protection procedures meet the requirements of the specifications; on-site inspection and spot checks of relevant records to confirm that the product protection meets the requirements.
	damage:
	a)Design and constructionAppropriate packagingandFreight Capacityinstrument;
	b)If packaging alone cannot provide protection, then necessary measures should be taken.Special conditions require documentation..
	If there are special requirements, then it should be…controlandremember
	record(See4.2.5).
7.6Surveillanceand measurement equipmentEquipment control	The organization should determineMonitoring and measurementAnd the necessary monitoring and measurementDeviceTo ensure that the product meets the specified requirementsProvide evidence.	*3.3.1	1)The inspection principles have further refined the requirements for the content of the usage records of inspection instruments and equipment;
	The organization shouldProgram documentationTo ensure surveillance andMeasurement activities are feasible and require monitoring and measurement.begConsistentImplemented in this manner.	It should be equipped withProduct inspection requirements are compatibleofInspectionTesting instrumentsandequipmentThe main testing instruments and equipment shouldWhen haveClear operating procedures.	2)The inspection principles emphasize measuring instrumentsRequirements;
	To ensure the validity of the results, the measuring equipment should, when necessary, include:	Verify whether the company possesses the relevant testing equipment by comparing it with the product inspection requirements and methods. Check whether operating procedures have been established for the main testing equipment.	3)13485It was emphasized that comparison can trace the source.To international and/or national standard measurementQuantity standard.
	a)The comparison can trace back toInternational and/or national standardsMeasurement Standards,according toSpecified time intervalOrBefore useconductCalibration or verification.	3.4.1
	If the above standards are not available, calibration or inspection should be recorded.	Testing instruments and equipment should be established.Usage RecordsThe record should includeUse, calibration, and maintenanceandrepairwaitCondition.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	The basis for determination(See4.2.5);	3.5.1
	b)conductAdjustmentor if necessaryreadjust; suchAdjustments or further adjustments should be madeRecord(See4.2.5);	Appropriate equipment should be providedMeasuring instrumentsMeasuring instrumentsMeasuring range and accuracyshouldMeets usage requirementsMeasuring instruments shall be marked with their…Calibration validity periodSave the corresponding recordrecord.
	c)getlogo,byDetermine its calibration statusstate;	Check the calibration records of the measuring instruments to determine if they are being used within their validity period.
	d)To prevent measurement results from becoming invalidofAdjustment;	8.1.1
	e)existTransportation and maintenanceandStorageperiodPrevent damageor failure.	It should be establishedQuality control proceduresRegulations for productsInspection departments, personnel, operations, etc.Require.
	The organization should perform calibration or verification in accordance with the documented procedures.	Check the quality control procedures to see if they specify the responsibilities of the product inspection department, personnel qualifications, and inspection operating procedures.
	In addition, whenThe equipment was found to be non-compliant.At that time, the organization	8.1.2
	Addressing previous measurement resultsValidityconductevaluateandRecord.	It should be stipulatedTesting instrumentsandequipmentofUse, CalibrationRequirements, and procedures for product release.
	The organization should take appropriate measures regarding the equipment and any affected products.measure.	Check the quality control procedures to see if they specify the use and calibration of testing instruments and equipment.
	Records of calibration and verification results should be maintained.(See	8.2.1
	4.2.5).	shouldregularTest instruments and equipmentcalibrationorInspectionand givelogo.
	Organizational response toMonitoring and measurement requirementsofcomputersoftwareThe application confirmation process is documented. This type of…The software should be available for initial use.Confirm before use.,appropriateAt that time, in this type of softwareAfter changes or during applicationConfirm	Check whether the testing instruments and equipment have been calibrated or verified as required and whether they have been labeled.8.2.2
	recognize.	It should be stipulated that testing instruments and equipment are subject to…Transportation, maintenance
	The specific methods and activities related to software verification and re-verification should be aligned with the risks associated with software use.This includes the impact on the product’s ability to conform to specifications.Internal risks.	During protection and storageProtection requirements,Preventing inspection resultsIf inaccurate.
	Results and confirmed conclusions, and measures taken as a result of confirmation.Records of necessary measures should be kept.(See4.2.4and4.2.5).	8.2.3
	Note: Further information can be found at [link/reference].ISO 10012.	whenThe testing instruments and equipment were found to be non-compliant.At that time, previous test results should be reviewed.evaluate, and saveVerification records.
		Review equipment usage and maintenance records to see if previous test results were evaluated and relevant records were kept when testing instruments and equipment failed to meet requirements.record.
		8.2.4
		For usetestofComputer softwareIt should be carried outConfirmrecognize.
8 TestQuantification, analysis and improvement	The organization should plan and implement the following aspects as requiredMonitoring, measuring, analyzing and improving processes:	*11.2.1	The inspection principles have been further refined to improve the monitoring system.Specific requirements.
8.1	a)Confirm product conformity;	Medical devices should be established in accordance with relevant regulations.Adverse event monitoring systemConduct adverse eventsMonitoring and re-evaluationWork, maintain relevantRecord.
General Principles	b)ConfirmQuality Management SystemofCompliance;	View the adverse events established by the enterprise.Monitoring system,
	c)Maintain the quality management systemValidity.	Is it stipulated?Suspicious adverse event management personnel
	This should include [the following]Statistical TechniquesIncludingAppropriate methods
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	andApplication levelThe determination.	Responsibilities, reporting principles, reporting procedures, and reporting deadlines,Formulate a plan to launch and implement medical devicesRe-evaluationThe process Order and files, etc., and symbolsCompliance requirementsReview relevant records to confirm whether any adverse events have occurred, and implement the required procedures accordingly.
		11.3.1
		It should be establishedData analysis programCollection and analysisRelated to product quality, adverse events, customer feedback, and the operation of the quality management system.Data verificationProduct safetyandValidityAnd keep relevant records.
		Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded.
8.2	8.2.1 feedback	9.5.1	No significant differences
Monitoring and measurementquantity	As a measure of the performance of the quality management system, the organization should address the relevant organizational…Have the customer’s needs been met? begInformation should be collected and monitored.Methods of acquiring and utilizing this informationCreate a document.	It should be establishedCustomer feedback handling procedureTo process customer feedback informationTracking analysis.
	The organization shouldFeedback systemThe program forms a file. ThisSuch a feedback process should include collecting feedback from…Productionand post-production activity dataAccording to the regulations.	Check whether the program documentation specifies the implementation of the above activities and whether customer feedback information is tracked and analyzed.
	The information collected during the feedback process should be able to provideMonitoring and maintaining product requirementsand providing product realization or improvement processesRisk Management PotentialInput.	11.3.1
	ifApplicable regulations requireThe organization received fromProductionPost-activity specific experienceThe review of this experience should constitute	A data analysis procedure should be established to collect and analyze data related to product quality, adverse events, andCustomer feedbackData related to the operation of the quality management system, verificationProduct safety and effectivenessAnd keep relevant records.
	It becomes part of the feedback process.	Review the implementation records of the data analysis to see if it was carried out according to the prescribed procedures, whether statistical techniques were applied, and whether records of the data analysis results were retained.
	8.2.2 Complaint handling	11.1.1	13485 Further refine the complaint handling proceduresSpecific requirements and responsibilities.
	The organization should base its decisions onApplicable laws and regulationsRequires timely handlingThe complaint procedure is documented..	Relevant departments should be designated to be responsible for receiving, investigating, evaluating, and processing the information.Customer complaintsand maintain relevantRecordReview relevant documents regarding responsibilities and authority to determine if the above activities are stipulated.
	These programs should include at least the followingRequirements and Responsibilities:	11.4.1
	a)Receive and record information;	It should be establishedCorrective action proceduresTo determine the cause of the problem, effective measures should be taken to prevent the problem from recurring.
	b)Evaluation information to determine whether feedback constitutes a voteLawsuit;
	c)Investigate complaints;
	d)SureReport the information to the appropriate regulatory authorities.demand;
	e)Processing andComplaints about related products;
	f)Determined to carry outThe need for correction or corrective action.ifThe complaint was not investigated.The reasons for such actions should be documented. Any corrections arising from the complaint handling process…
	Or corrective measures should be documented.
	If the investigation confirmsComplaints are activities outside the organization
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	ToThe relevant information should be inOrganizations and relevant external partiesInterchange.
	Complaint handling recordShould be maintained(See
	4.2.5).
	8.2.3 Report to regulatory agencies	*11.5.1	No significant differences
	Complaints that comply with the prescribed adverse event reporting guidelines are required by applicable regulations.Issue notices or advisory noticesThe organization shouldNotify appropriate supervisionDocumented procedures of the organization.	For medical devices that pose safety hazards, they should be handled in accordance with relevant regulations.Regulations require measures such as recalls.Measures, and in accordance with regulations, toReport from relevant departments.
	Reporting regulatory agency recordsShould be maintained	11.6.1
	(See4.2.5).	Products should be establishedInformation notification procedurePromptly deliverTasteChanges, UseWaiting for supplementary information notificationUser unit, related enterprise or consumer.
	8.2.4 Internal audit	11.7.1	13485The selection of auditors and the implementation of audits should be clearly defined to ensure the audit process is effective.Objectivity and impartiality; auditors should not auditCheck your own work.
	The organization should follow the plan.Time intervalconductInternal auditTo determine whether the quality management system is:	An internal audit procedure for the quality management system should be established, stipulating…The audit criteria, scope, frequency, participants, methods, record requirements, and assessment of the effectiveness of corrective and preventive actions.This includes ensuring that the quality management system complies with…This specificationRequirements.
	a)conform toPlanning and documented arrangements,This standardRequirements and the organization’s establishedQuality Management SystemRequirements andApplicable laws and regulationsRequire;	Check whether the internal audit process includes the above.Content. Review internal audit documents.Personnel conducting internal auditsyesnoAfter training,Internal audit recordsDoes it meet the requirements?Request: Have any measures been taken regarding the issues identified in the internal audit?correctPositive measures,whetherefficient.
	b)getEffective implementation and maintenance.
	The organization should document the procedures to describe them.Planning, implementation review, and reporting review resultsDuties andRequire.
	The audit program should be planned taking into account the status and importance of the areas and processes to be audited, as well as the results of previous audits. Audit procedures should be defined and documented.GuidelinesScope, Interval and Method(See4.2.5)AuditorThe selection and implementation of audits should ensure that the audit process is…Objectivity and impartiality.Auditors should not audit themselves
	My work.
	Records of the audit and its results, includingProcess identificationandAudited Areaandin conclusionThe record should be madeKeep.(See4.2.5).
	ResponsibleManagers of the audited areaAny necessary actions should be taken in a timely manner.Correction and corrective actionsTo eliminateThe identified nonconformities and their causes. Follow-up activities should…Including the measures takenVerification and verification resultsReport.
	Note: Further information can be found at [link/reference].ISO 19011.
	8.2.5 Process monitoring and measurement	8.3.2	13485Emphasizing that when the planned goals are not achievedAs a result, corrective measures should be taken where appropriate.Corrective measures.
	Organizations should adopt appropriate methods toQuality Management SystemSystem processconductSurveillanceWhen appropriate, quality managementSystem processMeasurementThese methods should be verified.Pass	Incoming inspection that requires routine controlProcess inspectionIn principle, finished product inspection items should not be outsourced for inspection. For inspections with high requirements for conditions and equipment, it is advisable to…
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Cheng’s ability to achieve the planned results.whenThe planned results were not achieved.When appropriate, measures should be taken.Correction and corrective actions.	For items requiring commissioned testing, a qualified institution can be commissioned to conduct the testing to prove that the product meets mandatory standards and the registered or filed product technical requirements.beg.
		8.4.2
		Inspection records should include incoming inspection,Process inspectionInspection records, inspection reports or certificates for finished products.Books, ecc.
	8.2.6 Product monitoring and measurement	*8.3.1	1)The inspection principles clarify that product technical requirements should be formulated in accordance with mandatory standards and registered or filed product technical requirements to develop product inspection procedures;
	Organizations should monitor and measure the characteristics of products to verify them.Product requirements have been met.Such monitoring and measurement should be based on the planned, documented arrangements and procedures during the product realization process.suitable	According toMandatory standardsand those that are registered or filedProduct Technical RequirementsDevelop product inspection procedures and issue corresponding certificates.Inspection report or certificate.checkCheck whether the product inspection procedures cover mandatory standards.In addition to verifying the performance indicators of the registered or filed product technical requirements; confirming whether the inspection records can prove that the product meets the requirements; and checking whether the corresponding inspection reports or certificates have been issued in accordance with the inspection procedures and inspection results..	2)The inspection principles have further refined the inspection requirements for the products;
	At this stageconduct.	8.3.2
	Should maintain complianceAcceptance CriteriaEvidence.Identification of personnel authorized to release productsIt should be recorded.(See	Requires routine controlIncoming inspection, process inspectionandFinished product inspectionProject in principleOutsourcing inspections is not allowed.TestFor testing conditions and equipment with high requirements,For items requiring testing outsourcing, a qualified testing agency can be commissioned.The agency conducts inspections to prove that the product complies with mandatory standards.Standards and technical requirements for registered or filed products.	3)Although13485not yetThis section emphasizes that each batch (unit) of products should have a batch inspection record. Record and meet traceability requirements.But in the previous section “7.5.1 Production and
	4.2.5)Where appropriate, records should identify the activities used to conduct the measurement.Test equipment.	*8.4.1	The phrase “control over service delivery” is mentioned.
	Only when the planned and documented arrangements have been successfully completedOnly when it is completedRelease products and delivery services.forImplantable medical devicesThe organization should keep recordstestand the identity of the test personnel.	Each batch (units)All products should haveBatch Inspection Recordrecordand satisfyTraceableRequire.	4)The relevant requirements for implantable medical devices should be referred to.
		8.4.2	《GMP Implantable medical devicesOn-site inspection guidelines.
		Inspection records should include the incoming…Goods inspection, process inspection and finished product inspectionTestRecords, inspection reports or certificatesBooks, etc..
		《GMP On-site inspection of implantable medical devicesGuiding Principles:
		*1.5.2
		It should have the correspondingQuality inspection agencyorfull-time inspectors.
		Check the organizational chart, departmental responsibilities, and personnel appointment documents to confirm whether they meet the requirements.
8.3	8.3.1 General Principles	10.1.1	No significant differences
Non-conforming productscontrol	The organization should ensureProducts that do not meet product requirementshave toarriveIdentificationandcontrolTo prevent itUnexpectedUse	It should be establishedNon-conforming product control proceduresThe regulations are not in complianceQuality controlResponsibilities and authority of departments and personnel.	No significant differences
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Or delivery. The organization shall stipulate.Non-conforming product controland regulationsNon-conforming product identification, documentation, isolation,evaluateandDisposal of substandard productsRelevant duties and authorities The program forms a file.	*10.2.1
	Unsatisfactory evaluationIt should include decisionsThe need to conduct an investigationand notification regarding thisAny external party responsible for non-compliance.	Non-conforming products should be inspected.Identification, recording, isolation,ReviewBased on the review results, appropriate measures should be taken against non-conforming products.Disposal measures.
	Should be maintainedNon-conforming natureAnd subsequentlyTake anyWhat measuresRecords, includingEvaluation, any surveyandRecord of the reasons for the decision(See4.2.5).	On-site inspections were conducted to verify whether the labeling and isolation of non-conforming products complied with the procedural documents, and random checks were performed on the non-conforming product handling records to ensure that the review was conducted in accordance with the document requirements.
	8.3.2Response measures for non-conforming products before delivery	*8.5.1	13485 More detailed pre-delivery non-conformitiesProduct response measures.
	Shi	Products should be specifiedRelease procedure,conditionandRelease batchStandard requirements.
	The organization should follow the followingOne or moreThe method of handling is notqualified products:	Check the product release procedure to see if the release process is clearly defined.
	a)takeMeasures to eliminate identified nonconformities;	Conditions and release approval requirements. The regulations should specify the conditions for releasing products.Personnel and their duties and authorityand should maintainapproveThe record.
	b)Take measuresTo prevent its original intended use or shoulduse;	8.5.2
	c)Authorization to use concessions,ReleaseorAccepting unqualifiedTaste.	The released products should be accompanied byCertificate of Conformity.
	The organization should ensure that non-conforming products are only produced after they have been supplied.combinereason,ApprovedandTo meet applicable regulationsbegIt can only be implemented under certain circumstances.Concession Acceptance.
	Concession Acceptance and Authorization of ConcessionsPersonnel identification records
	It should be maintained(See4.2.5).
	none	*9.1.1	1)13485Not separatelyCheng Zhang emphasized the requirements of sales, onlyIn the7.2.3 The communication chapter mentionsSome terms;
		Products should be establishedSales recordsand satisfyTraceableRequire.	2)Direct within ChinaSelling self-produced products or choosing medical device distributors must also comply with the requirements of the “Administrative Measures for the Operation of Medical Devices” and the “Good Manufacturing Practice for Medical Devices”.
		9.1.2
		Sales records should include at least:Medical device nameName, specifications, model, quantity, production batch number, and availability.
		Expiry date, sales date, name and address of the purchasing unit,Contact information, etc.content.
		9.2.1
		Direct sales of self-produced productsOr chooseMedical device distribution companiesIt should comply withMedical device related regulations and standards.
		9.2.2
		Medical device distributors were found to haveillegal and irregular Business activitiesAt that time, it should be reported toReport from the local food and drug administration department.
	8.3.3Response measures for non-conforming products after delivery	10.3.1	13485 The definition of advisory notices has been clarified.
	Shi	In productsAfter saleDiscover ProductsUnqualifiedAt that time, it should be done promptly.
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	whenAfter delivery or commencement of useWhen nonconforming products are discovered, the organization should take measures appropriate to the impact or potential impact of the nonconformity.Take measuresThe records should beTo maintain(See4.2.5).	Take action at the timeCorresponding measures,likeRecall, DestructionMeasures such as on-site inspection of products.When defects are found after sale
	The organization shouldComplies with applicable regulatory requirementsPublishedofAdviceThe program forms a fileThese processesThe procedure should be readily implementable. This differs from issuing advisory notices.	ofDisposal measures,whetherRecall and Destructionwait.
	ClosedMeasures RecordThis should be maintained.(See4.2.5).
	8.3.4 Rework	10.4.1	The inspection principles clearly state that items that cannot be reworked should be…When relevant handling systems are established.
	Considering the potential adverse effects of rework on the product consider,The organization should be based onDocumented proceduresImplementationReworkThese (rework) procedures should go through andSame as the original programofReview and approval.	Defective products canReworkYes, enterprises should preparereturnWork control documentsRework control documentation should include…doIndustry guidelines, re-inspection and re-verification, etc.content.
	After rework, the product should undergo…verifyEnsure itsComplies with applicable acceptance criteria and regulatory requirements..	Check the rework control documents to see if any rework is permitted.Regulations on non-conforming productsRandomly check rework activity records to confirm whether they comply with the requirements of the rework control documents.
	Rework should be maintainedRecord(See4.2.5).	10.4.2
		No reworkYes, it should be establishedRelated handling system
		Spend.
8.4	Organizations should identify, collect, and analyze appropriate data.According to, to confirmThe suitability and effectiveness of the quality management systemefficacyThe program should be documented.statisticsTechnology and its application scopeanddegreeIncludingAppropriate methodsThe determination.	11.3.1	13485 The data analysis has been further refined.Specific input content.
Data Analysis	Data analysis should include…The monitoring measurement generateddataandData from other relevant sourcesAt least including	A data analysis program should be established to collect and analyze data.Related to product quality, adverse events, customer feedback, and the operation of the quality management system.The data is used to verify product safety and effectiveness, and relevant records are maintained.
	The following inputs are required:	Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded.
	a)feedback;
	b)andProduct compliance;
	c)Processes and productsCharacteristics and Trendsincluding takingPreventive measuresOpportunity;
	d)Supplier;
	e)Review;
	f)When appropriate,Service Report.
	If data analysis showsInadequate quality management systemshould,Inadequate or ineffectiveThe organization should follow80.5 ofThis analysis should be used as input for improvement.
	Records of data analysis results should be kept.(See4.2.5).
8.5	8.5.1 General Principles	*1.3.2	No significant differences.13485 The knowledge was slightly refined.Don’t implement any necessary changes.
improve	Organizations should utilizeQuality policy, quality objectives, audit	The management representative shall be responsible for establishing, implementing, and maintaining [the system/system].
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	Results, post-market surveillance, data analysis, corrective andPreventive measures and management reviewComeIdentificationandImplementationAny necessaryChangeTo ensure and maintain quality controlTheoretical systemSustained suitability and adequacyandValidityas well asSafety and performance of medical devices.	Quality management system, reporting on the operation of the quality management system andImprovement requirementsThis will raise employees’ awareness of meeting regulations, rules, and customer requirements.	Use the method.
		Check whether the above responsibilities are clearly defined. Review the management representative’s report on quality management.System operation ConditionandimproveRelated records.
		*11.8.1
		Management reviews should be conducted regularly to evaluate and audit the quality management system to ensure its effectiveness.Sustained suitability and adequacyandValidity.
		Review management review documents and records, including the management review plan, management review report, E…Related improvement measuresDoes the management review report include a review of the law?
		Evaluation of compliance. Whether a management review was conducted within the stipulated timeframe, whether improvement measures were proposed and specific responsibilities and requirements were implemented, and whether the plan was followed.Shi.
	8.5.2 Corrective measures	11.4.1	No significant differences.13485 Slightly refinedRequirements for corrective actions.
	The organization should takemeasureTo eliminate the non-conforming original	It should be establishedCorrective action procedures,SureThe cause of the problem,takeEffective measures,preventRelatedThe problem occurred again..
	Therefore, to prevent the recurrence of nonconformities, any necessary corrective actions should be taken promptly. The corrective actions should be commensurate with the severity of the impact of the nonconformity.	11.7.1
	Organizations shouldDocumented procedures, in order to stipulate	An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, methods, and record requirements.correctpreventionEvaluation of the effectiveness of measures, etc.Content to ensure that the quality management system complies with the requirements of this specification.
	The following requirements:	Check if the internal audit procedures include the above. Review the internal audit documents and identify the personnel who conducted the internal audit.
	a)Unsatisfactory review(includeCustomer complaints);	Whether training was conducted, whether internal audit records meet requirements, and whether issues identified during internal audits were addressed.Corrective measures were taken.,Is it effective?.
	b)SureReasons for non-compliance;
	c)Evaluation ensures failureMeasures to prevent it from happening againofneed;
	d)Plan and take the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files;
	e)verifyCorrective measuresFailure to meet applicable regulatory requirementsorAdverse effects on the safety and performance of medical devices;
	f)ReviewThe measures takenCorrective measuresofValidity.anyinvestigationandTake measuresofRecordShould be maintained
	(See4.2.5).
	8.5.3 Preventive measures	11.4.2	No significant differences.13485 Slightly refinedRequirements for preventive measures.
	The organization should identify measures to eliminateReasons for potential non-complianceTo prevent nonconformities from occurring, preventative measures should be appropriate to the severity of the potential problem.	It should be establishedPreventive measures procedures,SurePotential problemsReasons,takeEffective measures,To prevent problems from occurring.
	The organization should establish documented procedures to describe the following:beg:	11.7.1
	a) SurePotential nonconformities and their causes;	An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, methods, record requirements, and corrective actions.Preventive measures include
ISO 13485:2016		New versionGMP/Inspection principles	A Brief Analysis of Differences
	b)evaluatePreventing non-conformitiesmeasuresneed;	Evaluation of effectiveness, etc.Content to ensure that the quality management system complies with the requirements of this specification.
	c)planAnd the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files;	Check whether the internal audit procedures include the above-mentioned content. Review internal audit documents to verify whether the personnel conducting the internal audit have received training and whether the internal audit records meet the requirements.
	d)verifyPreventive measuresIt does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device.;	Request: Regarding the issues identified in the internal audit,Corrective measures were taken
	e)When appropriate,ReviewThe preventive measures takenValidity.	Positive measures,Is it effective?.
	anyinvestigationand the measures takenmeasureofRecordShould be protected
	hold(See4.2.5).